1. Pink Sheet

Pediatric Cancer Studies: US FDA Promises Flexible Approach On Requirements

 
• By Sue Sutter

FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.

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The US FDA is promising to take a flexible, transparent approach to the development and implementation of new pediatric study requirements for certain cancer drugs under the FDA Reauthorization Act (FDARA).

The agency intends use a transparent process to generate a list of molecular targets potentially relevant to pediatric cancers and will use that list as guidepost in deciding whether sponsors of novel drugs and biologics must conduct studies under the Pediatric Research Equity Act

However, agency officials emphasized that the molecular target list will not amount to the be-all/end-all for determining whether sponsors must conduct pediatric studies of cancer drugs, and they noted the

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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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• By Joseph Haas and Nielsen Hobbs

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